EP3498195A1 - Wiederverwendbarer chirurgischer klammerapplikator mit mehrfachauslösung - Google Patents
Wiederverwendbarer chirurgischer klammerapplikator mit mehrfachauslösung Download PDFInfo
- Publication number
- EP3498195A1 EP3498195A1 EP18212043.6A EP18212043A EP3498195A1 EP 3498195 A1 EP3498195 A1 EP 3498195A1 EP 18212043 A EP18212043 A EP 18212043A EP 3498195 A1 EP3498195 A1 EP 3498195A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- proximal
- assembly
- distal
- handle
- drive member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
- A61B34/35—Surgical robots for telesurgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0023—Surgical instruments, devices or methods, e.g. tourniquets disposable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00407—Ratchet means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
- A61B2017/00473—Distal part, e.g. tip or head
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00477—Coupling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/30—Surgical robots
- A61B2034/302—Surgical robots specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0803—Counting the number of times an instrument is used
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0813—Accessories designed for easy sterilising, i.e. re-usable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0814—Preventing re-use
Definitions
- the present disclosure relates to surgical clip appliers and, more particularly, to a reposable multi-fire surgical clip applier including a handle assembly, a shaft assembly, and a clip cartridge assembly that are configured for selective disassembly to facilitate disposal of any disposable component(s) and reprocessing of any reusable component(s) for further use.
- Clip appliers that are able to apply multiple clips during a single entry into a body cavity, for example, are described in commonly-assigned U.S. Pat. Nos. 5,084,057 and 5,100,420 to Green et al. , the entire contents of which are incorporated herein by reference.
- Another multiple clip applier is disclosed in commonly-assigned U.S. Pat. No. 5,607,436 by Pratt et al. , the entire contents of which is also hereby incorporated herein by reference.
- U.S. Pat. No. 5,695,502 to Pier et al. discloses a resterilizable surgical clip applier that is configured to receive and cooperate with an interchangeable clip magazine so as to advance and form multiple clips during a single entry into a body cavity.
- the present disclosure relates to a reposable multi-fire surgical clip applier including a handle assembly, a shaft assembly, and a clip cartridge assembly that are configured for selective disassembly to facilitate disposal of any disposable component(s) and reprocessing of any reusable component(s) for further use.
- a reposable surgical clip applier provided in accordance with aspects of the present disclosure includes a handle assembly, a shaft assembly releasably engagable with the handle assembly, and a clip cartridge assembly releasably engagable within the shaft assembly.
- the handle assembly includes a housing, at least one handle movable relative to the housing between a spaced-apart position and an approximated position, and an inner actuation assembly extending from the housing.
- the inner actuation assembly includes a proximal drive member movable through the housing, a proximal pusher bar movable through the proximal drive member, and a proximal biasing member disposed about the proximal drive member between a proximal end portion of the housing and a proximal end portion of the proximal drive member.
- the proximal biasing member has a bias configured to move the proximal drive member proximally such that the proximal pusher bar is moved distally. Movement of the at least one handle relative to the housing is configured to move the proximal drive member and the proximal pusher bar in relative opposing directions.
- the shaft assembly includes an outer tube, a jaw assembly supported at a distal end portion of the outer tube, and an inner drive slidably disposed within the outer tube and operably coupled to the jaw assembly such that distal movement of the inner drive through the outer tube actuates the jaw assembly.
- the clip cartridge assembly retains a stack of surgical clips therein and includes a distal pusher operably coupled to a distal-most surgical clip of the stack of surgical clips such that distal movement of the distal pusher loads the distal-most surgical clip into the jaw assembly when the clip cartridge assembly is releasably engaged within the shaft assembly.
- the proximal drive member is positioned proximally adjacent the inner drive assembly such that movement of the at least one handle towards the approximated position actuates the jaw assembly
- the proximal pusher bar is positioned proximally adjacent the distal pusher such that movement of the at least one handle towards the spaced-apart position loads the distal-most surgical clip into the jaw assembly.
- the housing includes at least one internal feature defining a pivot recess configured to movably receive a distal end portion of the at least one handle.
- the pivot recess and the at least one handle are sized and configured to cooperate to limit movement of the at least one handle beyond a predetermined approximated position and beyond a predetermined spaced-apart position.
- movement of the at least one handle towards the approximated position moves the proximal drive member distally about the proximal pusher bar, against the bias of the proximal biasing member, and moves the proximal pusher bar proximally about and through the proximal drive member.
- movement of the at least one handle towards the spaced-apart position moves the proximal drive member proximally about the proximal pusher bar, under the bias of the proximal biasing member, and moves the proximal pusher bar distally about and through the proximal drive member.
- the handle assembly further includes a ratchet assembly having at least one ratchet pawl pivotably supported within the housing and a ratchet rack supported on a distal end portion of the proximal drive member.
- the at least one ratchet pawl is operably positioned relative to the ratchet rack to provide ratchet functionality to the inner actuation assembly.
- the outer tube of the shaft assembly includes at least one window formed through a tubular proximal segment thereof.
- the proximal segment of the outer tube is positioned adjacent the ratchet assembly, such that, the at least one ratchet pawl is disposed within the at least one window to engage the ratchet rack.
- the shaft assembly further includes an inner bushing disposed between the tubular proximal segment and the inner drive assembly.
- the inner bushing includes at least one window configured to be axially aligned with the at least one window of the tubular proximal segment when the inner bushing is disposed therein, such that, the at least one ratchet pawl is disposed within the at least one window of the tubular proximal segment and the at least one window of the inner bushing to engage the ratchet rack.
- the housing of the handle assembly includes an open distal mouth portion defining a central passageway and a protrusion extending inwardly into the central passageway.
- the tubular proximal segment of the outer tube defines a slot and the inner bushing defines a cutout configured to be axially aligned with the slot of the tubular proximal segment when the inner bushing is disposed therein.
- the slot of the outer tube and the cutout of the inner bushing are configured to cooperate to receive the protrusion of the housing upon insertion of the shaft assembly into the open distal mouth portion of the housing to releasably engage the shaft assembly with the handle assembly.
- the inner drive assembly includes a proximal plunger having a proximal neck portion.
- the proximal neck portion of the proximal plunger is configured to be received within a distal end portion of the proximal drive member to operably couple the inner drive assembly and the proximal drive member.
- the proximal drive member includes an inner sleeve adjacent the distal end portion thereof.
- the inner sleeve is configured to receive the proximal neck portion of the proximal plunger of the inner drive assembly, such that, the proximal pusher bar is movable to extend through the proximal drive member and through the proximal plunger of the inner drive assembly to engage the distal pusher of the clip cartridge assembly.
- the proximal drive member includes a lumen configured to slidably support the proximal pusher bar.
- the proximal plunger of the inner drive assembly includes a hub lumen configured to be in communication with the lumen of the proximal drive bar when the proximal neck portion of the proximal plunger is disposed within the inner sleeve of the proximal drive member, such that, the proximal pusher bar is movable to extend through the lumen of the proximal drive member and through the hub lumen of the proximal plunger of the inner drive assembly to engage the distal pusher of the clip cartridge assembly.
- the handle assembly includes a pair of handles pivotably coupled to the housing and extending from opposed sides thereof.
- the handle assembly further includes a linkage assembly configured to pivotably couple the pair of handles to the inner actuation assembly.
- the linkage assembly includes a first link arm configured to operably couple a first handle of the pair of handles to the proximal drive member and a second link arm configured to operably couple a second handle of the pair of handles to the proximal pusher bar.
- the first link arm upon movement of the pair of handles towards the approximated position, the first link arm is configured to move the proximal drive member distally and the second link arm is configured to move the proximal pusher bar proximally.
- the first link arm upon movement of the pair of handles towards the spaced-apart position, the first link arm is configured to move the proximal drive member proximally and the second link arm is configured to move the proximal pusher bar distally.
- the linkage assembly is configured to move the proximal drive member concurrently with the proximal pusher bar upon movement of the pair of handles.
- the linkage assembly further includes a third link arm configured to operably couple the second handle of the pair of handles to the proximal drive member and a fourth link arm configured to operably couple the first handle of the pair of handles to the proximal pusher bar.
- the first link arm and the third link arm are coupled to a proximal end portion of the proximal drive member via a pivot boss having a bore extending therethrough.
- the proximal drive member includes a lumen configured to be in communication with the bore of the pivot boss, such that, the proximal pusher bar is movable to extend through the bore of the pivot boss and through the lumen of the proximal drive member upon movement of the pair of handles.
- the proximal pusher bar is configured to move between the first link arm and the third link arm as the proximal pusher bar moves through the bore of the pivot boss and through the lumen of the proximal drive member.
- the clip cartridge assembly further includes a biasing member configured to bias the distal pusher proximally.
- the clip cartridge assembly further includes a cartridge housing having a support base configured to support at least a portion of the distal pusher.
- the support base includes a distal bridge portion and a proximal bridge portion, wherein the biasing member of the cartridge assembly is operably coupled to the distal pusher and to the proximal bridge portion to bias the distal pusher proximally.
- the clip cartridge assembly further includes a clip carrier including a pair of engagement flanges.
- the cartridge housing includes a pair of internal grooves extending longitudinally along at least a portion of a length of the cartridge housing.
- the pair of internal grooves are configured to laterally receive the pair of engagement flanges, respectively, to inhibit axial movement of the clip carrier relative to the cartridge housing.
- the clip cartridge assembly further includes a carrier lock disposed proximally adjacent a proximal end portion of the clip carrier, the carrier lock including a pair of opposing arms configured to biasingly engage a pair of opposing internal walls of the cartridge housing.
- the carrier lock is configured to inhibit proximal movement of the clip carrier relative to the cartridge housing beyond the carrier lock.
- proximal refers to the end portion of the apparatus or component thereof which is closer to the user and the term “distal” refers to the end portion of the apparatus or component thereof which is further away from the user.
- Surgical clip applier 10 includes a handle assembly 100, a shaft assembly 200 extending distally from handle assembly 100, and a clip cartridge assembly 300 mounted within shaft assembly 200.
- Shaft assembly 200 is removably and selectively engagable with handle assembly 100 and clip cartridge assembly 300 is removably and selectively mountable within shaft assembly 200.
- Handle assembly 100 and shaft assembly 200 may be configured as sterilizable, reusable components, while clip cartridge assembly 300 may be configured as a single-procedure-use component.
- a stack of surgical clips "C" FIG.
- each actuation of handle assembly 100 actuates cooperating drive components of handle assembly 100, shaft assembly 200, and cartridge assembly 300 to fire and form a single surgical clip from the stack of surgical clips "C" ( FIG. 3 ) around a vessel or other tissue to ligate the vessel or other tissue.
- clip cartridge assembly 300 includes a cartridge housing or housing 310, a clip carrier 320, a clip follower 330, a distal pusher 340, a slider 350, a first biasing member 360, a second biasing member 370, a carrier lock 380, and a stack of surgical clips "C.”
- cartridge housing 310 includes an upper housing portion 310a, a lower housing portion 310b, and an internal cavity 312 extending along a length of the cartridge housing 310 between a distal end portion and a proximal end portion thereof.
- Cartridge housing 310 may be formed at least partially from a transparent material, such as, for example, a transparent plastic, to enable visualization into internal cavity 312 thereof.
- Cartridge housing 310 includes a pair of internal grooves 314a, 314b extending longitudinally along at least a portion of the length of the cartridge housing 310, on opposing internal walls 311a, 311b thereof.
- the pair of internal grooves 314a, 314b are configured to retain clip carrier 320 and carrier lock 380 when clip carrier 320 and carrier lock 380 are disposed within internal cavity 312 of cartridge housing 310, as will be detailed below.
- Internal cavity 312 of cartridge housing 310 is also configured to receive at least a portion of clip follower 330, distal pusher 340, slider 350, first biasing member 360, second biasing member 370, and the stack of surgical clips "C" therein.
- upper housing portion 310a of cartridge housing 310 includes a window 316 formed therein and configured to slidably receive a cap portion 352 of slider 350.
- Cartridge housing 310 includes a protrusion 317 extending transversely into proximal window 316 from a side thereof.
- Cap portion 352 of slider 350 defines a more-proximally positioned recess 353a defined on a side thereof and a more-distally positioned recess 353b defined on the same side thereof. More-proximally positioned recess 353a is configured to receive protrusion 317 of cartridge housing 310 to releasably retain slider 350 in a distal position relative to cartridge housing 310.
- protrusion 317 of cartridge housing 310 is dislodged from more-proximally positioned recess 353a of cap portion 352 of slider 350, enabling slider 350 to slide proximally through window 316.
- protrusion 317 is engaged within more-distally positioned recess 353b of cap portion 354 of slider 350 to thereby releasably retain slider 350 in a proximal position relative to cartridge housing 310.
- the proximal and distal positions of slider 350 are described in detail hereinbelow.
- lower housing portion 310b of cartridge housing 310 includes a support base 313 configured to enclose and support at least a portion of distal pusher 340 when distal pusher is disposed within internal cavity 312 of cartridge housing 310 ( FIG. 5 ).
- Support base 313 includes a first or distal bridge portion 313a and a second or proximal bridge portion 313b extending between and coupled to lateral sides of cartridge housing 310.
- the first and second bridge portions 313a, 313b are longitudinally spaced apart and at least a portion of distal pusher 340 is disposed thereon.
- Second bridge portion 313b includes an aperture or slot 313c configured to receive a proximal end portion 372 of second biasing member 370 thus fixing proximal end portion 372 of second biasing member 370 relative to cartridge housing 310, as will be further detailed below.
- lower housing portion 310b of cartridge housing 310 may include more than two bridge portions or may be entirely enclosed.
- clip carrier 320 of clip cartridge assembly 300 includes a floor 324 and a pair of side walls 326a, 326b extending longitudinally along the opposed sides of floor 324 such that clip carrier 320 defines a generally U-shaped configuration.
- Clip carrier 320 includes a pair of engagement flanges 322a, 322b configured to engage the pair of internal grooves 314a, 314b of opposing internal walls 311a, 311b, respectively, of cartridge housing 310.
- the pair engagement flanges 322a, 322b extend laterally from the pair of side walls 326a, 326b, respectively, and are disposed within the pair of internal grooves 314a, 314b of cartridge housing 310 to prevent axial movement of clip carrier 320 relative to cartridge housing 310.
- carrier lock 380 includes a body 382 having a central arm 384a, a pair of side arms 384b, 384c disposed on opposing lateral sides of central arm 384a and outwardly biased therefrom, and a pair of legs 386a, 386b folded below and under a proximal end portion of body 382.
- Each side arm 384b, 384c includes a tang 388a, 388b, respectively, extending outwardly therefrom.
- Internal cavity 312 of cartridge housing 310 is configured to receive carrier lock 380 such that the pair of side arms 384b, 384c are slidably disposed within internal grooves 314a, 314b, respectively, of cartridge housing 310.
- Cartridge housing 310 includes a pair of slots 318a, 318b extending through opposing internal walls 311a, 311b.
- the pair of slots 318a, 318b are positioned and configured to receive the pair of tangs 388a, 388b extending outwardly from the pair of side arms 384b, 384c, respectively, to releasably retain carrier lock 380 within internal cavity 312 of cartridge housing 310.
- Each of the pair of tangs 388a, 388b includes a proximal portion 389a that is substantially parallel relative to a respective proximal portion of the pair of slots 318a, 318b and a distal portion 389b that is angled relative to a respective distal portion of the pair of slots 318a, 318b.
- carrier lock 380 is configured for positioning proximally adjacent a proximal end portion of clip carrier 320 such that central arm 384a of carrier lock 380 is disposed in abutting relation therewith.
- carrier lock 380 is slidably retained within internal cavity 312 via engagement between the pair of tangs 388a, 388b and the pair of slots 318a, 318b, clip carrier 320 is inhibited from moving proximally beyond central arm 384a of carrier lock 380. In this manner, clip carrier 320 is retained within internal cavity 312 of cartridge housing 310.
- the pair of legs 386a, 386b of carrier lock 380 is folded below and under the proximal end portion of body 382 to define an angle " ⁇ " therebetween.
- angle " ⁇ " is less than 90 degrees. This effectively forms a four-bar linkage mechanism providing for easier cleaning and sterilization, all in a more robust design having fewer parts.
- the pair of legs 386a, 386b of carrier lock 380 is configured to be supported by a base 243a of a distal drive bar 242 of shaft assembly 200.
- clip carrier 320 further includes a resilient central tang 328 extending upwardly from floor 322 towards a distal end portion of clip carrier 320.
- Resilient central tang 328 is configured to engage a backspan of a distal-most surgical clip "C1" of the stack of surgical clips “C” to retain the stack of surgical clips "C” within clip carrier 320.
- Clip carrier 320 further includes a leg 329 depending from an underside of floor 322 adjacent a proximal end portion thereof.
- clip follower 330 of clip cartridge assembly 300 includes a distal sled 332 slidably disposed within clip carrier 320 proximally of the stack of surgical clips "C.”
- Distal sled 332 of clip follower 330 is configured for positioning proximally adjacent a proximal-most clip "C2" of the stack of surgical clips "C” in abutting relation therewith.
- Distal sled 332 further defines a pair of slots 333 therethrough, as detailed below.
- Clip follower 330 further includes an elongated rod 334 extending proximally from distal sled 332.
- Elongated rod 334 defines a fixed distal end engaged to distal sled 332 and a free proximal end that is slidably disposed within a lumen 355 defined within base portion 354 of slider 350.
- First biasing member 360 is disposed about elongated rod 334 of clip follower 330 between distal sled 332 and base portion 354 of slider 350 so as to bias distal sled 332 distally into and against the proximal-most clip "C2" of the stack of surgical clips "C,” thereby biasing the stack of surgical clips "C” distally.
- first biasing member 360 may take the form of a coil spring, a constant force spring, a power spring, or another suitable biasing element.
- distal pusher 340 of clip cartridge assembly 300 is slidably disposed about an underside of clip carrier 320, opposite clip follower 330.
- Distal pusher 340 includes a pair of pusher flanges 342 at a distal end portion thereof that are configured to urge the distal-most surgical clip "C1" of the stack of surgical clips “C” distally over resilient central tang 328 of clip carrier 320 and distally from clip cartridge assembly 300 into jaws 238 ( FIG. 10 ).
- Distal pusher 340 further includes a proximal slot 344 defined therethrough adjacent a proximal end portion thereof that is configured to slidably receive leg 329 of clip carrier 320 to maintain distal pusher 340 and clip carrier 320 in alignment with one another while permitting distal pusher 340 to slide longitudinally relative to clip carrier 320. Specifically, distal pusher 340 is permitted to slide longitudinally relative to clip carrier 320 until a position where leg 329 of clip carrier 320 abuts a proximal end portion or a distal end portion of proximal slot 344 of distal pusher 340.
- Distal pusher 340 also includes a flange or tab 346 depending from an underside thereof at an intermediate portion of distal pusher 340.
- Tab 346 is configured to receive a distal end portion 374 of second biasing member 370 such that the distal end portion 374 of second biasing member 370 is fixed relative to distal pusher 340.
- second biasing member 370 serves to bias distal pusher 340 proximally relative to cartridge housing 310 and, thus, clip carrier 320 and the stack of surgical clips "C.”
- Distal pusher 340 additionally includes a proximally-facing pusher surface 348 disposed at the proximal end portion thereof.
- Proximally-facing pusher surface 348 may be part of a proximal extension 349 that is monolithically formed with distal pusher 340 and folded below and under the proximal end portion thereof to define proximally-facing pusher surface 348.
- slider 350 of clip cartridge assembly 300 includes a base portion 354 and a cap portion 352 disposed on base portion 354.
- Cap portion 352 is configured for slidable receipt within window 316 of cartridge housing 310 and is releasably engagable therein in either a proximal position or a distal position.
- base portion 354 of slider 350 In the distal position, does not extend proximally beyond the proximal end portion of cartridge housing 310. In the proximal position, base portion 354 extends proximally beyond the proximal end portion of cartridge housing 310.
- movement of slider 350 between the distal and proximal position enables selective locking and unlocking of clip cartridge assembly 300 within shaft assembly 200 ( FIG. 1 ).
- Base portion 354 of slider 350 defines a lumen 355 extending longitudinally therethrough.
- Lumen 355 is configured to slidably receive elongated rod 334 of clip follower 330, as shown in FIGS. 7 and 8 .
- Cap portion 352 of slider 350 may define a textured, such as, for example, grooved, upper surface 356 to facilitate gripping cap portion 352 of slider 350 to slide slider 350 between the proximal and distal positions.
- the stack of surgical clips "C,” as detailed above, is supported within clip carrier 320 with the clips thereof arranged in tip-to-tail orientation.
- Each of the surgical clips of the stack of surgical clips “C” includes a pair of legs interconnected by a backspan.
- the stack of surgical clips “C” includes a lockout clip “LC” ( FIG. 22 ) positioned proximally of the proximal-most clip “C2".
- the lockout clip “LC” is formed as a solid disc and may be distinctively marked and/or colored. Providing the lockout clip "LC” in this manner enables the user to visually determine or at least estimate the number of surgical clips remaining by viewing the position of the lockout clip "LC” through cartridge housing 310.
- the lockout clip "LC,” if loaded into jaws 238 ( FIG. 23 ), also serves as a lockout, as detailed below.
- shaft assembly 200 includes an outer tube 210, an inner sleeve or bushing 220, a jaw assembly 230, and an inner drive assembly 240.
- Outer tube 210 includes an open distal end portion 212, an open proximal end portion 214, a lumen 216 extending between and communicating with the open distal and proximal end portions, 212, 214, respectively, and an elongated cut-out 218 defined through a side wall of outer tube 210 and communicating with lumen 216 therethrough.
- Outer tube 210 further includes a jaws support member 211 extending distally from open distal end portion 212.
- jaws support member 211 extends distally from a lower portion of outer tube 210 and towards an upper portion of outer tube 210 to define a support surface 211a.
- Elongated cut-out 218 is spaced-apart from open distal end portion 212 of outer tube 210 such that outer tube 210 defines a tubular distal segment 219a disposed distally of elongated cut-out 218.
- tubular distal segment 219a of outer tube 210 may include indicia "I" configured to enable the user to visually determine or at least estimate the number of surgical clips remaining by viewing the position of the lockout clip "LC" through cartridge housing 310.
- Elongated cut-out 218 is also spaced-apart from open proximal end portion 214 of outer tube 210 such that outer tube defines a tubular proximal segment 219b disposed proximally of elongated cut-out 218.
- Tubular proximal segment 219b includes a recess or slot 219c configured to engage handle assembly 100 ( FIG. 16 ) to selectively couple shaft assembly 200 and handle assembly 100, as detailed below.
- tubular proximal segment 219b may include more than one slot 219c ( FIG. 11 ).
- Tubular proximal segment 219b further includes a window 219d formed therethrough and configured for receiving a ratchet pawl 146 ( FIG. 16 ) of a ratchet assembly of handle assembly 100, as detailed below.
- tubular proximal segment 219b may include more than one window 219d formed through opposing lateral sides thereof ( FIG. 12 ).
- inner bushing 220 is disposed within tubular proximal segment 219b of outer tube 210.
- Inner bushing 220 includes an open distal end 222, an open proximal end 224, a lumen 226 extending between and communicating with the open distal and proximal ends, 222, 224, respectively, and an elongated slot or cutout 228 defined through a side wall of inner bushing 220 and extending proximally from open distal end 222.
- inner bushing 220 may include more than one slot 228.
- Inner bushing further includes one or more window(s) 229 ( FIG. 10 ) formed through opposing lateral sides thereof.
- one or more slot(s) 219c of outer tube 210 and one or more cutout(s) 228 of inner bushing 220 are sized and aligningly configured to engage handle assembly 100 ( FIG. 16 ) to selectively couple outer tube 210 and inner bushing 220 of shaft assembly 200, with handle assembly 100, as detailed below.
- one or more window(s) 219d of outer tube 210 and one or more window(s) 229 of inner bushing 220 are sized and aligningly configured to receive ratchet pawl 146 ( FIG. 16 ) of the ratchet assembly of handle assembly 100, as detailed below.
- jaw assembly 230 includes a stationary base 232 and a jaws component 236.
- Stationary base 232 is affixed within outer tube 210 to an interior surface thereof, via welding or other suitable methods.
- Stationary base 232 includes a proximal base portion 233, a central block 234, and a distal base portion 235.
- Jaws component 236 includes a proximal hub 237a, a bifurcated neck 237b, and a pair of jaws 238, one of which is attached to the free distal end of each of the bifurcated portions of bifurcated neck 237b.
- Proximal hub 237a of jaws component 236 defines a slot 237c configured to receive central block 234 of stationary base 232 to engage and fixedly maintain jaws component 236 within outer tube 210. With jaws component 236 engaged about stationary base 232 in this manner, jaws 238 extend distally from open distal end 212 of outer tube 210.
- Jaws 238 of jaw assembly 230 are biased apart from one another via bifurcated neck 237b. Jaws 238 define outwardly-facing cam surfaces 239a and inwardly-facing channels 239b.
- a distal drive bar 242 of inner drive assembly 240 is configured to engage cam surfaces 239a of jaws 238 and urge jaws 238 towards one another, as detailed below.
- Inwardly-facing channels 239b of jaws 238 are configured to receive the legs of a surgical clip from the stack of surgical clips "C" therein to retain the surgical clip within the jaws 238 during formation thereof, as also detailed below.
- inner drive assembly 240 of shaft assembly 200 includes a distal drive bar 242 and a proximal drive plunger 244.
- Distal drive bar 242 includes a base 243a and a pair of side walls 243b extending longitudinally along opposing sides of base 243a so as to define an inner channel 243c extending longitudinally along distal drive bar 242.
- Distal drive bar 242 of inner drive assembly 240 further includes a boxed distal end portion 243d and a slot 243e defined through base 243a towards the boxed distal end portion 243d thereof.
- Distal drive bar 242 is slidably disposed within lumen 216 of outer tube 210.
- Slot 243e of distal drive bar 242 is configured to slidably receive stationary base 232 of jaw assembly 230 therethrough to enable distal drive bar 242 to slide within outer tube 210 and about stationary base 232.
- Boxed distal end portion 243d of distal drive bar 242 is configured for positioning about bifurcated neck 237b of jaw assembly 230.
- distal drive bar 242 Upon distal advancement of distal drive bar 242, as detailed below, boxed distal end portion 243d of distal drive bar 242 is advanced distally about jaws component 236 to cam about cam surfaces 239a of jaws 238 to thereby urge jaws 238 towards one another.
- Proximal drive plunger 244 of inner drive assembly 240 is slidably disposed within lumen 226 of inner bushing 220, when inner bushing 220 is disposed within tubular proximal segment 219b of outer tube 210.
- Proximal drive plunger 244 includes a hub 245 having a distal body portion 245a having an outer diameter "Dl”, a proximal neck portion 245b having an outer diameter "D2" that is less than diameter "Dl” of distal body portion 245a, and a shoulder 245c at an intermediate portion thereof, defined by the transition from outer diameter "Dl" of distal body portion 245a to outer diameter "D2" of proximal neck portion 245b.
- Hub 245 includes an open distal end portion 246a adjacent distal body portion 245a, an open proximal end portion 246b adjacent proximal neck portion 245b, and a hub lumen 247 extending between distal and proximal body portions 245a, 245b and communicating with the open distal and proximal end portions, 246a, 246b, respectively.
- Open distal end portion 246a of hub 245 is engaged with a proximal end portion of inner channel 243c of distal drive bar 242 such that hub lumen 247 is in communication with inner channel 243c of distal drive bar 242.
- Hub 245 further includes a threaded opening or bore 249 configured to receive a lock screw 250 ( FIG. 16 ) to releasably fix distal drive bar 242 and an outer drive tube 142 of handle assembly 100, as detailed below.
- Jaws component 236 and inner drive assembly 240 are removable from outer tube 210 to facilitate reprocessing of the various components thereof for reuse.
- jaws component 236, led by proximal hub 237a thereof, is inserted proximally through open distal end 212 of outer tube 210 until slot 237c of jaws component 236 is aligned above central block 234 of stationary base 232.
- Inner bushing 220 led by open distal end 222, is inserted distally through open proximal end 214 of outer tube 210 and slid distally about tubular proximal segment 219b of outer tube 210 until inner bushing 220 is disposed within lumen 216 such that, one or more slot(s) 219c of outer tube 210 and one or more cutout(s) 228 of inner bushing 220 are each axially aligned, respectively, and one or more window(s) 219d of outer tube 210 and one or more window(s) 229 of inner bushing 220 are each axially aligned, respectively.
- inner drive assembly 240 led by boxed distal end portion 243d of distal drive bar 242, is inserted distally through open proximal end 214 of outer tube 210 and open proximal end 224 of inner bushing 220, and slid distally about jaws component 236 until boxed distal end portion 243d of distal drive bar 242 is disposed about bifurcated neck 237b of jaws component 236, such that proximal hub 237a of jaws component 236 is disposed above slot 243e of base 243a of distal drive bar 242, and such that hub 245 of proximal drive plunger 244 is disposed within lumen 226 of inner bushing 220.
- proximal hub 237a of jaws component 236 may be engaged with stationary base 232 through slot 243e of base 243a of distal drive bar 242. More specifically, proximal hub 237a of jaws component 236 is urged towards central block 234 of stationary base 232 such that central block 234 is received within slot 237c of jaws component 236. With jaws component 236 engaged with stationary base 232 in this manner, stationary base 232 extends at least partially through slot 243e of base 243a of distal drive bar 242 and boxed distal end portion 243d of distal drive bar 242 is disposed about bifurcated neck 237b of jaws component 236.
- outer tube 210, inner bushing 220, jaws component 236, and inner drive assembly 240 are operably engaged with one another.
- shaft assembly 200 is assembled as illustrated in FIGS. 10 and 13
- lumen 216 of outer tube 210, lumen 226 of inner bushing 220, and hub lumen 247 of distal drive bar 242 are in communication with one another to slidably receive handle assembly 100, as detailed below.
- Disengagement and removal of jaws component 236, inner bushing 220, and inner drive assembly 240 from outer tube 210 are effected in the opposite manner of the above-detailed insertion and engagement.
- handle assembly 100 includes a housing 110, a pair of handles 130, an inner actuation assembly 140, and a linkage assembly 160.
- Housing 110 includes an upper housing portion 112 and lower housing portion 114 secured to one another by a plurality of screws 116, although other suitable engagements are also contemplated.
- Each housing portion 112, 114 further includes a pair of pivot recesses 117 defined by internal features, such as, for example, internal arcuate walls 119.
- Each pivot recess 117 has a substantially "V" shaped configuration with a tapered distal end portion 117a and an open proximal end portion 117b.
- Each pivot recess 117 includes a width "Wl" adjacent open proximal end portion 117b which gradually decreases towards tapered distal end portion 117a thereof. Pivot recesses 117 are configured to enable movement of the pair of handles 130, respectively, about housing 110 between a spaced-apart position ( FIG. 1 ) and an approximated position ( FIG. 2 ). Respective widths "Wl" of each pivot recess 117 and a width "W2" of each handle 130 is configured to cooperate, at least in part, to limit movement of the pair of handles 130 beyond a predetermined maximum spaced-apart position and beyond a predetermined maximum approximated position.
- housing 110 includes an open distal mouth portion 126a configured to receive a proximal end portion of shaft assembly 200 therethrough to releasably engage shaft assembly 200 with handle assembly 100, as detailed below.
- Open distal mouth portion 126a is formed from cooperating mouth portions of upper housing portion 112 and lower housing portion 114 and defines a central passageway 118.
- Housing 110 also includes an open proximal end portion 126b formed from cooperating portions of upper housing portion 112 and lower housing portion 114.
- Central passageway 118 extends between and is in communication with open distal mouth portion 126a and open proximal end portion 126b.
- At least one of the upper and lower housing portions 112, 114 includes a tab or protrusion 128 ( FIG. 15 ) adjacent open distal mouth portion 126a and extending radially inwardly into central passageway 118.
- Protrusion 128 is configured to releasably engage slot(s) 219c ( FIG. 14 ) of tubular proximal segment 219b and cutout(s) 228 ( FIG. 14 ) of inner bushing 220, respectively, such that outer tube 210 and inner bushing 220 are releasably fixed to housing 110, to releasably engage shaft assembly 200 with handle assembly 100, as detailed below.
- At least one of the upper and lower housing portions 112, 114 include one or more pawl slots(s) or groove(s) 127 formed therein.
- Pawl groove 127 has a substantially triangular profile and is defined by internal features of housing 110, such as, for example, a pair of groove walls 129a.
- Each pawl groove 127 further includes a pivot bore 129b defined in an internal corner between the pair of groove walls 129a.
- Each pawl groove 127 is configured to pivotably support a ratchet pawl 146 of a ratchet assembly, as will be detailed below.
- handles 130 of handle assembly 100 are pivotably coupled to housing 110 and extend outwardly from opposing sides thereof. More specifically, each handle 130 includes a pivot bore 132 at the distal end portion thereof and a finger loop 134 at the proximal end portion thereof. Each of the distal end portions of handles 130 are disposed within the respective pivot recess 117 of housing 110 such that the plurality of screws 116 extend through at least one of the upper and lower housing portions 112, 114 and through pivot bores 132 to enable pivoting of handles 130 relative to housing 110 between a spaced-apart position and an approximated position. Finger loops 134 facilitate manipulation of handles 130 to pivot handles 130 between the spaced-apart and approximated positions.
- inner actuation assembly 140 includes a proximal drive member such as, for example, outer drive tube 142, a ratchet assembly having a ratchet rack 144 and a pair of ratchet pawls 146, a proximal pusher bar 148, and a proximal biasing member 150.
- a proximal drive member such as, for example, outer drive tube 142
- a ratchet assembly having a ratchet rack 144 and a pair of ratchet pawls 146
- a proximal pusher bar 148 a proximal pusher bar 148
- Outer drive tube 142 includes a body portion 143 having an inner sleeve 143a adjacent a distal end portion thereof, a proximal collar 143b disposed about a proximal end portion thereof, a substantially flat mounting portion 143c extending proximally from proximal collar 143b, and a lumen 143d extending longitudinally between the distal and proximal end portions of body portion 143 in communication with inner sleeve 143a and mounting portion 143c.
- inner sleeve 143a extends through body portion 143, proximally from the distal end portion thereof, and includes a proximal sleeve wall 141 disposed within body portion 143.
- Proximal sleeve wall 141 includes an opening or aperture 141a in communication with lumen 143d of body portion 143 such that, inner sleeve 143a is in communication with lumen 143d of body portion 143.
- inner sleeve 143a is configured to slidably receive hub 245 of proximal drive plunger 244 of inner drive assembly 240 of shaft assembly 200.
- inner sleeve 143a includes a threaded opening or bore 141b configured to be axially aligned with bore 249 of hub 245 when hub 245 is disposed within inner sleeve 143a.
- Bore 141b of inner sleeve 143a and bore 249 of hub 245 are configured to cooperate to receive a lock screw 250 ( FIG. 16 ) to movably couple distal drive bar 242 and outer drive tube 142.
- hub lumen 247 is configured to be in communication with lumen 143d of body portion 143 such that, proximal pusher bar 148 is movable to extend through lumen 143d of body portion 143 in slidable relation relative thereto, through hub lumen 247 of hub 245 in slidable relation relative thereto, and distally from hub 245, as will be detailed below.
- ratchet rack 144 of the ratchet assembly is fixedly supported on outer drive tube 142 towards the distal end portion of body portion 143 and defines first and second sets of teeth 145 extending along opposed sides thereof.
- Each of the first and second sets of teeth 145 extend longitudinally between a first and second set of distal and proximal rack clearances 147a, 147b, respectively, disposed on opposed sides of body portion 143.
- the first and second sets of teeth 145 are configured to engage first and second ratchet pawls 146, respectively.
- Each ratchet pawl 146 has a substantially triangular profile, having a distal tooth 146a, a proximal tooth 146b, and a pivot member or post 146c defined at a remote corner of ratchet pawl 146, furthest from ratchet rack 144.
- Pivot post 146c of each ratchet pawl 146 is configured to be received within respective pivot bores 129 of pawl grooves 127 such that each ratchet pawl 146 is pivotably supported within respective pawl grooves 127 of housing 110.
- ratchet pawls 146 are configured to toggle between a first position ( FIG. 17A ) and a second position ( FIG. 17B ).
- a first pawl wall adjacent distal tooth 146a abuts or is engaged with first groove wall 129a adjacent distal tooth 146a and proximal tooth 146b is engaged or in registration with teeth 145 of ratchet rack 144 until proximal tooth 146b is received within distal rack clearance 147a, wherein the orientation of ratchet pawl 146 is flipped to enable toggling towards the second position.
- FIG. 17A in the first position of ratchet pawls 146, a first pawl wall adjacent distal tooth 146a abuts or is engaged with first groove wall 129a adjacent distal tooth 146a and proximal tooth 146b is engaged or in registration with teeth 145 of ratchet rack 144 until proximal tooth 146b is received within distal rack clearance 147a, wherein the orientation
- ratchet pawls 146 are operably positioned relative to the first and second sets of teeth 145 of ratchet rack 144 to provide ratchet functionality to inner actuation assembly 140, as will be detailed below.
- ratchet functionality of ratchet pawls 146 and ratchet rack 144 is configured to provide an audible click and/or a tactile vibration, indicating that handles 130 are being moved through an actuation or a return stroke.
- the ratchet functionality of ratchet pawls 146 and ratchet rack 144 further provides a safety mechanism to avoid inadvertent partial clip formation and inadvertent firing of a partially formed clip.
- the four-bar linkage mechanism will automatically tend to flip the direction of ratchet pawls 146 when handles 130 are released.
- proximal biasing member 150 is disposed about body portion 143 of outer drive tube 142.
- a distal end portion 152a of proximal biasing member 150 abuts a proximal wall of housing 110, adjacent open proximal end portion 126b thereof, while a proximal end portion of proximal biasing member 160 abuts proximal collar 143b of body portion 143 of outer drive tube 142.
- proximal biasing member 150 is provided to bias outer drive tube 142 proximally towards a proximal-most position thereof, as will be detailed below.
- proximal biasing member 150 serves to bias the pair of handles 130 towards the spaced-apart position relative to housing 110 ( FIG. 1 ), as will be detailed below.
- Handle assembly 100 further includes a linkage assembly 160 configured to pivotably couple handles 130 to inner actuation assembly 140.
- Linkage assembly 160 includes a first link arm 162, a second link arm 164, a third link arm 166, and a fourth link arm 168.
- Each of the first and second link arms 162, 164 are pivotably coupled at a first end portion thereof to an intermediate portion of one of the handles 130 via a first pivot boss 161a and each of the third and fourth link arms 166, 168 are pivotably coupled at a first end portion thereof to an intermediate portion of the other of the handles 130 via a second pivot boss 161b.
- Each of the first and fourth link arms 162, 168 are internally pivotably coupled at mounting portion 143c of outer drive tube 142 adjacent the proximal end portion of body 143 via a third pivot boss 161c.
- Each of the second and third link arms 164, 166 are internally pivotably coupled at a second end portion thereof to a pusher mount 148a adjacent the proximal end portion of proximal pusher bar 148 via a fourth pivot boss 161d.
- third pivot boss 161c includes a bore 163 extending therethrough and configured to be in communication with lumen 143d of outer drive tube 142.
- proximal pusher bar 148 extends between first and fourth link arms 162, 168, through bore 163 of third pivot boss 161c, in slidable relation thereto, and distally through lumen 143d of outer drive tube 142.
- first, second, third, and fourth link arms 162, 164, 166, and 168 are disposed such that each of the intermediate portions of handles 130, mounting portion 143c of outer drive tube 142, and pusher mount 148a of proximal pusher bar 148 are sandwiched between respective portions of first, second, third, and fourth link arms 162, 164, 166, and 168 as described above.
- each of the first, second, third, and fourth pivot bosses 161a, 161b, 161c, and 161d includes a locking element 165 configured to inhibit axial movement and inadvertent release of the first, second, third, and fourth pivot bosses 161a, 161b, 161c, and 161d when linkage assembly 160 is assembled as described above.
- outer drive tube 142 is disposed in the proximal-most position, while proximal pusher bar 148 is disposed in a distal-most position.
- first and fourth link arms 162, 168 urge outer drive tube 142 distally, and second and third link arms 164, 166 pull proximal pusher bar 148 proximally.
- linkage assembly 160 is configured to move outer drive tube 142 concurrently with proximal pusher bar 148.
- proximal biasing member 150 is compressed between the proximal wall of housing 110, adjacent open proximal end portion 126b thereof and proximal collar 143b of body portion 143 of outer drive tube 142, as outer drive tube 142 is urged distally by first and fourth link arms 162, 168 of linkage assembly 160. In this manner, the handles 130 are moved through an actuation stroke against the bias of proximal biasing member 150.
- the predetermined maximum approximated position is determined, at least in part, by the cooperation between width "Wl" of each pivot recess 117 of housing 110 and width "W2" of each handle 130, respectively.
- ratchet pawls 146 are disposed in the second position. Specifically, as outer drive tube 142, and ratchet rack 144 fixed thereon, are urged distally, the second pawl wall adjacent proximal tooth 146b abuts or is engaged with second groove wall 129a adjacent proximal tooth 146b and distal tooth 146a is engaged or in registration with teeth 145 of ratchet rack 144 to provide an audible click and/or a tactile vibration, indicating that handles 130 are being moved through an actuation stroke.
- distal tooth 146a is received within proximal rack clearance 147b such that the orientation of ratchet pawl 146 is flipped to enable toggling towards the first position ( FIG. 17A ), and provide an end-of-stroke audible click and/or tactile vibration.
- handles 130 Upon release or return of handles 130 towards the spaced-apart position ( FIG. 1 ) relative to housing 110, handles 130 move first and fourth link arms 162, 168 to pull outer drive tube 142 proximally, and move second and third link arms 164, 166 to urge proximal pusher bar 148 distally. It is contemplated that as handles 130 are pivoted towards the spaced-apart position, linkage assembly 160 is configured to move outer drive tube 142 concurrently with proximal pusher bar 148. With handles 130 disposed in the spaced-apart position relative to housing 110, outer drive tube 142 is disposed in the proximal-most position, while proximal pusher bar 148 is disposed in the distal-most position.
- handle spring assembly 144 engages the handles 130 such that handles 130 are moved through a return stroke with the outward bias of spring arms 147.
- the bias of handle spring assembly 144 is configured to pull outer drive tube 142 proximally and urge proximal pusher bar 148 distally.
- the predetermined maximum spaced-apart position is determined, at least in part, by the cooperation between width "Wl" of each pivot recess 117 of housing 110 and width "W2" of each handle 130, respectively.
- ratchet pawls 146 are disposed in the first position. Specifically, as outer drive tube 142, and ratchet rack 144 fixed thereon, are pulled proximally, the first pawl wall adjacent distal tooth 146a abuts or is engaged with first groove wall 129a adjacent distal tooth 146a and proximal tooth 146b is engaged or in registration with teeth 145 of ratchet rack 144 to provide an audible click and/or a tactile vibration, indicating that handles 130 are being moved through a return stroke.
- proximal tooth 146b is received within distal rack clearance 147a such that the orientation of ratchet pawl 146 is flipped to enable toggling back towards the second position ( FIG. 17B ), and provide an end-of-return audible click and/or tactile vibration.
- handle assembly 100, shaft assembly 200, and clip cartridge assembly 300, if not preassembled, are individually assembled, as detailed above. Thereafter, shaft assembly 200 is engaged with handle assembly 100, as detailed below.
- shaft assembly 200 in order to engage shaft assembly 200 with handle assembly 100, the proximal end portion of shaft assembly 200 is inserted proximally into open distal mouth portion 126a of housing 110. More specifically, shaft assembly 200 is moved proximally relative to handle assembly 100 such that tubular proximal segment 219b of outer tube 210 of shaft assembly 200 is inserted proximally into central passageway 118 until the proximal end portion of shaft assembly 200 is disposed adjacent an inner proximal wall of housing 110 and protrusion 128 is received within slot 219c ( FIG. 10 ) of tubular proximal segment 219b and cutout 228 ( FIG.
- windows 219d of outer tube 210 and windows 229 of inner bushing 220 are axially aligned and configured to cooperate to receive ratchet pawls 146 of handle assembly 100 therethrough.
- the plurality of screws 116 may be removed or loosened to space apart upper housing portion 112 and lower housing portion 114 such that slots 219c ( FIG. 10 ) of tubular proximal segment 219b and cutouts 228 ( FIG. 10 ) of inner bushing 220 may be aligned with protrusion 128.
- upper housing portion 112 and lower housing portion 114 may be secured to one another by the plurality of screws 116.
- inner sleeve 143a of body portion 143 of outer drive tube 142 slidably receives proximal neck portion 245b of hub 245 of inner drive assembly 240 until shoulder 245c of hub 245 is positioned adjacent the distal end portion of body portion 143 and open proximal end portion 246b of hub 245 is positioned adjacent proximal sleeve wall 141 disposed within body portion 143.
- lock screw 250 FIG.
- proximal pusher bar 148 disposed within lumen 143d of outer drive tube 142, is received within, and extends through hub lumen 247 of hub 245 of proximal drive plunger 244 of inner drive assembly 240 of shaft assembly 200.
- proximal pusher bar 148 extends through lumen 143d of body 143 of outer drive tube 142 in slidable relation relative thereto, through hub lumen 247 of hub 245 in slidable relation relative thereto, and distally from open distal end portion 246a of hub 245.
- slider 350 of clip cartridge assembly 300 if not already in the distal position, is moved to the distal position, wherein base portion 354 of slider 350 does not extend proximally beyond the proximal end portion of cartridge housing 310 and wherein more-proximally positioned recess 353a of cap portion 352 of slider 350 is engaged within protrusion 317 of cartridge housing 310 to retain slider 350 in the distal position.
- clip cartridge assembly 300 is inserted through elongated cut-out 218 of outer tube 210 of shaft assembly 200 and distally relative to outer tube 210 such that the distal end portion of cartridge housing 310 ducks under tubular distal segment 219a of outer tube 210 and extends through the portion of lumen 216 defined by tubular distal segment 219a of outer tube 210.
- the remainder of clip cartridge assembly 300 is inserted through elongated cut-out 218 to be seated within lumen 216 of outer tube 210.
- slider 350 is urged proximally such that protrusion 317 of cartridge housing 310 is dislodged from more-proximally positioned recess 353a of cap portion 352 of slider 350, slider 350 is slid proximally through window 316, and protrusion 317 is engaged within more-distally positioned recess 353b of cap portion 352 of slider 350 to retain slider 350 in the proximal position.
- base portion 354 of slider 350 extends proximally beyond the proximal end portion of cartridge housing 310 and into tubular proximal segment 219b of outer tube 210.
- base portion 354 of slider 350 extending into tubular proximal segment 219b of outer tube 210 and the distal end portion of cartridge housing 310 extending through tubular distal segment 219a of outer tube 210, clip cartridge assembly 300 is locked in engagement within shaft assembly 200. Disengagement and removal of clip cartridge assembly 300 is effected in the opposite manner as the insertion and engagement detailed above.
- handles 130 of handle assembly 100 are moved to and maintained in the approximated position during the above-noted insertion of clip cartridge assembly 300 into shaft assembly 200, although handles 130 need not be maintained in the approximated position during movement of slider 350 to lock clip cartridge assembly 300 within shaft assembly 200.
- proximal pusher bar 148 is disposed in the proximal-most position such that, proximal pusher bar 148 does not interfere with the insertion of clip cartridge assembly 300 into shaft assembly 200. Rather, proximal pusher bar 148, in the proximal-most position thereof, is maintained proximally of proximally-facing pusher surface 348 of distal pusher 340 of clip cartridge assembly 300.
- handles 130 may be released or returned towards the spaced-apart position ( FIG. 1 ) such that proximal pusher bar 148 is moved distally through lumen 143d of outer drive tube 142 and towards the distal-most position of proximal pusher bar 148.
- proximal pusher bar 148 is moved distally, a distal end portion of proximal pusher bar 148 is urged into proximally-facing pusher surface 348 of distal pusher 340 to thereby urge distal pusher 340 distally.
- surgical clip applier 10 is manipulated such that a vessel (or other tissue), to be ligated, is disposed between jaws 238.
- handles 130 are moved from the spaced-apart position ( FIG. 1 ) towards the approximated position ( FIG. 2 ).
- outer drive tube 142 is urged distally.
- proximal drive plunger 244 which is coupled to outer drive tube 142 via lock screw 250, is in turn moved distally to thereby urge distal drive bar 242 distally.
- distal drive bar 242 As distal drive bar 242 is advanced distally, boxed distal end portion 243d of distal drive bar 242 is advanced distally to cam about cam surfaces 239a of jaws 238, thereby urging jaws 238 towards one another to form the surgical clip loaded therein about the vessel (or other tissue).
- handles 130 may be released or returned towards the spaced-apart position such that the next distal-most surgical clip "C1" of the stack of surgical clips "C” is loaded into jaws 238 for subsequent firing.
- the above-detailed use of surgical clip applier 10 may be repeated to fire a plurality of surgical clips from the stack of surgical clips "C” until only the lockout clip "LC" remains.
- distal pusher 340 is moved distally such that pusher flanges 342 thereof engage a proximally-facing edge of the lockout clip “LC” and urges the lockout clip “LC” distally from clip cartridge assembly 300 into inwardly-facing channels 239b of jaws 238. Since the lockout clip "LC” is formed as a solid disc, jaws 238 are inhibited from being moved towards one another when the lockout clip "LC” is disposed therebetween.
- handles 130 actuation of handles 130 is inhibited.
- sled 332 of clip follower 330 is moved to the distal end portion of clip carrier 320 under the bias of first biasing member 360.
- pusher flanges 342 are moved proximally in response to the release or return of handles 130 towards the spaced-apart position, pusher flanges 342 are engaged within slots 333 of sled 332 of clip follower 330 to further inhibit subsequent actuation of handles 130.
- clip-less firing of surgical clip applier 10 is inhibited.
- surgical clip applier 10 be capable of loading different surgical clip cartridge assemblies 300 within shaft assembly 200.
- surgical clip applier 10 may be loaded with a clip cartridge assembly 300 having a stack of surgical clips "C" of a particular size and/or configuration.
- a first clip cartridge assembly 300 having a stack of surgical clips "C” of a first size or a second clip cartridge assembly 300 having a stack of surgical clips "C” of a second size different than the first size may be loaded into shaft assembly 200.
- the user may remove the clip cartridge assembly 300 being used in favor of a different clip cartridge assembly 300.
- the present disclosure further contemplates a surgical kit including one handle assembly 100, one shaft assembly 200, and one or more clip cartridge assemblies 300 (similar or different from one another).
- the kit may also include instructions for the assembly of surgical clip applier 10, the use of surgical clip applier 10, and/or the reprocessing of reusable components of surgical clip applier 10 following use.
- a package, container, or box may also be provided.
- Surgical instruments such as the clip applier(s), or components thereof, described herein may also be configured to work with robotic surgical systems and what is commonly referred to as "Telesurgery.”
- Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation.
- Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment.
- Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
- the robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location.
- one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely control the instruments via the robotic surgical system.
- a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.
- the robotic arms of the surgical system are typically coupled to a pair of master handles by a controller.
- the handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the embodiments described herein.
- the movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon.
- the scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).
- the master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions.
- the master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.
- a medical work station is shown generally as work station 1000 and generally may include a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004.
- Operating console 1005 may include a display device 1006, which may be set up in particular to display three-dimensional images; and manual input devices 1007, 1008, by means of which a person (not shown), for example a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode.
- Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and an attaching device 1009, 1011, to which may be attached, for example, a surgical tool "ST" supporting an end effector 1100, in accordance with any one of several embodiments disclosed herein, as will be described in greater detail below.
- Robot arms 1002, 1003 may be driven by electric drives (not shown) that are connected to control device 1004.
- Control device 1004 e.g., a computer
- Control device 1004 may be set up to activate the drives, in particular by means of a computer program, in such a way that robot arms 1002, 1003, their attaching devices 1009, 1011 and thus the surgical tool (including end effector 1100) execute a desired movement according to a movement defined by means of manual input devices 1007, 1008.
- Control device 1004 may also be set up in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the drives.
- Medical work station 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner by means of end effector 1100. Medical work station 1000 may also include more than two robot arms 1002, 1003, the additional robot arms likewise being connected to control device 1004 and being telemanipulatable by means of operating console 1005. A medical instrument or surgical tool (including an end effector 1100) may also be attached to the additional robot arm. Medical work station 1000 may include a database 1014, in particular coupled to with control device 1004, in which are stored, for example, pre-operative data from patient/living being 1013 and/or anatomical atlases.
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762598445P | 2017-12-13 | 2017-12-13 | |
US16/142,197 US10743887B2 (en) | 2017-12-13 | 2018-09-26 | Reposable multi-fire surgical clip applier |
Publications (2)
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EP18212043.6A Active EP3498195B1 (de) | 2017-12-13 | 2018-12-12 | Wiederverwendbarer chirurgischer klammerapplikator mit mehrfachauslösung |
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US (1) | US10743887B2 (de) |
EP (1) | EP3498195B1 (de) |
JP (1) | JP2019103799A (de) |
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-
2018
- 2018-09-26 US US16/142,197 patent/US10743887B2/en active Active
- 2018-11-08 AU AU2018260894A patent/AU2018260894A1/en not_active Abandoned
- 2018-12-04 JP JP2018227222A patent/JP2019103799A/ja not_active Ceased
- 2018-12-10 CN CN201811502465.1A patent/CN109907794A/zh active Pending
- 2018-12-12 EP EP18212043.6A patent/EP3498195B1/de active Active
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Also Published As
Publication number | Publication date |
---|---|
AU2018260894A1 (en) | 2019-06-27 |
EP3498195B1 (de) | 2020-07-22 |
CN109907794A (zh) | 2019-06-21 |
US20190175189A1 (en) | 2019-06-13 |
US10743887B2 (en) | 2020-08-18 |
JP2019103799A (ja) | 2019-06-27 |
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